SPIFE ALKALINE HEMOGLOBIN

K982426 · Helena Laboratories · JBD · Dec 17, 1998 · Hematology

Device Facts

• Record ID: K982426
• Device Name: SPIFE ALKALINE HEMOGLOBIN
• Applicant: Helena Laboratories
• Product Code: JBD · Hematology
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7440
• Device Class: Class 2

Indications for Use

The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use.

Device Story

SPIFE Alkaline Hemoglobin system performs qualitative and semi-quantitative analysis of abnormal hemoglobins. Input: human blood samples. Process: agarose gel electrophoresis on SPIFE Analyzer; separation of hemoglobin variants based on electrophoretic mobility. Output: visual/semi-quantitative assessment of hemoglobin bands. Used in clinical laboratories by trained technicians. Results assist clinicians in screening for hemoglobinopathies. Benefits: rapid, standardized identification of abnormal hemoglobin patterns compared to manual methods.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

System utilizes agarose gel electrophoresis for hemoglobin separation. Components include SPIFE Analyzer, agarose gels, and associated reagents. Operates as an in vitro diagnostic system for laboratory use. No specific materials or software algorithms detailed in the provided documentation.

Indications for Use

Indicated for the qualitative and semi-quantitative determination of abnormal hemoglobins in human blood samples via agarose electrophoresis. Used as a screening method for in vitro diagnostic purposes in clinical laboratory settings.

Regulatory Classification

Identification

An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.

Submission Summary (Full Text)

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Public Health Service

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DEC 1 7 1998

Ms. Pat Franks Asst. Director, Requlatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752

K982426 Re: SPIFE Alkaline Hemoglobin Kit Trade Name: Regulatory Class: II Product Code: JBD Dated: July 7, 1998 Received: July 13, 1998

Dear Ms. Franks:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbrandinq by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

SPIFE Alkaline Hemoglobin Device Name:

Indications for Use:

The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use.

Putre Madin'

(Division Sign-Off) Division of Clinical Laboratory Devices K982436 510(k) Number _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)